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TITLE 21 - CMC Ready-To-Go Series

Title 21 Ready-To-Go CMC Drug Development Know-how Series is available to Drug Development Association members or new membership only.
IAGIM Membership for The Title 21 Ready-To-Go CMC Drug Development Know-how Series is available to three year IAGIM members or via the many Extended Development Benefit Plans. Title 21 consists of essential CMC know-how (Chemistry Manufacturing and Control Data) - Save up to six months on development qualification scale-up and end process product validation

Title 19 - GENERIC DRUG DEVELOPMENT HANDBOOK

Non IAGIM members may purchase Title 19 Series, known under the collective title of the Handbook of Pharmaceutical Generic Development Series. This Handbook Series (collectively known as the '120+ Series') is targeted at an advanced drug development and plant production postgraduate level and covers each and every aspect of drug development (including extensive Development Reports - FDA style) for the specific target drug.

Title 19 - COMPLETE USA DATA PACKAGE

These Handbooks are suitable as complete authoritative reference works for the particular target drug in question (whether Tamoxifen or Nabumatone or other generics) and contain detailed chapters on the actual drug development as well as complete production CMC dossiers, suitable for immediate commercial production, similar to the database found at the commercial production level in the Tile 21 Ready-To-Go CMC Series.

DOWNLOAD the Ready-To-Go List (PDF Format)
Handbook of Pharmaceutical Generic Development Series list may be downloaded at the click of a button.
PDF Format

Title 21 - CMC DATA SPECIFICATIONS :

Title 21 R-T-Go Data know-how package may be shipped in two separate ways:

Electronic CMC - Abbreviated [Title 21 by e-mail PDF] - Expedited Level Only

Electronic CD - Full quarterly updated data on CD [Air shipped quarterly]

CDs with updated data are shipped during March, June, September and December.

Price in US $ (Product lists are simplified guides only)

Data Package for Single and Multiple Strength Drug Products are calculated on request. The displayed list prices are guides only and are based on the lowest number of strengths. Where multiple strengths occur the cost is increased proportionally.

EU files add additional 25 - 45% to price of US CMC Files

Price in US $ (Product lists are simplified guides only)

Immediate Release Tablets/Caplets, Capsules & Softgels; Suspensions etc.

EU files add additional 25 - 45% to price of US CMC Files

Controlled Release Tablets/Caplets, Capsules

Data Package for Single or Multiple Strengths Drug Products are available

Complex Drugs (e.g. Paclitaxel Inj. 6mg/mL 30 & 100 mg vials - see product lists)

Expedited shipping levels jump to first place in the shipping queue for an extra 15%

EULA and IAGIM Rules

EULA and IAGIM Rules & Regulations apply to Title 21 Ready-To-Go CMC Series. Expedited shipping levels jump to first place in the shipping queue for an extra 15%

COPYRIGHT & INTELLECTUAL PROPERTY

Handbook of Pharmaceutical Generic Development Series & CMC Series - Standard rules of copyright and intellectual property apply. Where IAGIM members are developing generic products for third parties who are not IAGIM members, then the Primary IAGIM Member (the developer) is required to enroll the third party as a secondary member for three years IAGIM membership subscription period. (Copyright & Intellectual Property Rule.) Thus no third party may receive CMC IAGIM data without being a paid-up member. CMC products are not for resale or distribution and are shipped to registered IAGIM members in accordance with the registered address as stated on the IAGIM membership certificate.

READY-TO-GO CMC SERIES
FULL GENERIC DRUG DEVELOPMENT CMC LIST - CLICK HERE

US CMC | EURO CMC | JAPAN CMC